Schizophrenia
Conditions
Keywords
Catecholamines, Dopamine, Clinical Trial, fMRI, PFC, Vitamin B2, Riboflavin, Tolcapone, Placebo, Normal Volunteers, Schizophrenia, Healthy Volunteers, HV
Brief summary
This study will evaluate whether Tolcapone improves cognition in healthy volunteers as well as patients with schizophrenia. Talcapone is a drug that has been FDA approved for Attention Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain. ...
Detailed description
Psychopharmacological modulation of the catecholaminergic system can enhance some aspects of cognitive function. For example, COMT inhibitors can slightly improve working memory/executive function. Differences in the response between individuals might be related to a number of factors, including variations in the genes. The recent finding that a polymorphism in the catechol-o-methyl-transferase (COMT) gene, which produces a 4 fold change in enzyme activity, accounts for 4 percent of the variance in performance of working memory tasks in humans suggest that COMT genotype may predict response to COMT inhibitors. In the present investigation our goal is to examine, in normal controls and patients with schizophrenia, the effect of a centrally acting (tolcapone) and of a peripherally acting (entacapone) COMT inhibitor on cognitive function. We predict that both normal controls and patients with schizophrenia with the val/val genotype will have a significant, though transient, improvement in working memory in subjects treated with tolcapone but not in those treated with entacapone. Furthermore, in conjunction with other NIMH imaging protocols, we would like to examine the neurophysiological correlates related to working memory. We predict, in tolcapone treated subjects, improved measures in prefrontal 'efficiency' in subjects and patients specifically with the val/val genotype. The present protocol will provide new insights on the importance of this genetic polymorphism in the regulation of aminergic-controlled cognitive function in normal individuals. Furthermore, this protocol will test whether COMT inhibitors offer a new treatment-based on genotype - for cognitive impairment in schizophrenia. No IND is required for the present study.
Interventions
OTHERPlacebo
Placebo: One capsule 3 times a day from Day 1 to Day 7
DRUGTolcapone
Tolcapone: One capsule 3 times a day from Day 1 to Day 7
Sponsors
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* INCLUSION CRITERIA: 1. Prior participation under NIH protocol number 95-M-0150, or new normal volunteers or schizophrenic patients that meet criteria for NIH protocol number 95-M-0150 (NCT00001486). 2. No Axis I or Axis II diagnosis in normal volunteers. 3. Age range: 18-50 years.
Exclusion criteria
1. Normal volunteers with an Axis I or Axis II disorder obtained either from prior SCID interview in Protocol 95-M-0150 or through a screening interview will be excluded. 2. Subjects with a history of cardiovascular disease, liver disease and other medical illnesses, and untreated or uncontrolled hypertension will be excluded. An electrocardiogram, blood pressure, pulse rate and metabolic panel including LFTs will be checked on all subjects prior to participation in the study. Individuals with persistent tardive dyskinesia or abnormal LFTs, or individuals with significant history of alcoholism or liver enzyme elevation will be excluded from the study. 3. Schizophrenic patients taking clozapine, a COMT inhibitor, any illicit drugs of abuse, or MAO inhibitors will be excluded. 4. Normal control subjects taking any medications other than occasional NSAI will be excluded. 5. Pregnant women. Women of childbearing potential will undergo a urine pregnancy test the day the study initiates and screened by history for the possibility of pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| N-Back Task Activation by Genotype in Patients With Schizophrenia | At end of treatment period (at 7th day for first intervention and at 21st day for second intervention) | Activation beta values (N-Back vs. 0-Back) extracted from DLPFC from the contrast maps in Patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks. |
| N-Back Task Performance | At end of treatment period (at 7th day for first intervention and at 21st day for second intervention) | Working Memory was measured in HVs and patients with schizophrenia after a 7-day treatment with Tolcapone or placebo in a double-blind, cross-over fashion. The working memory was quantified by taking the number of trials entered correctly divided by the total number of trials multiplied by 100. Values range from 0 to 100. Zero indicates the poorest performance while 100 indicates perfect performance. |
| N-Back Task Activation Diagnosis Effect | At end of treatment period (at 7th day for first intervention and at 21st day for second intervention) | Activation beta values (N-Back vs. 0-Back) were extracted within the Main Effect of Diagnosis cluster around the peak (p \< 0.05 uncorrected) from the contrast maps in the Placebo condition. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks. |
| N-Back Task Activation Drug Effect | At end of treatment period (at 7th day for first intervention and at 21st day for second intervention) | Activation beta values (N-Back vs. 0-Back) extracted within the Main Effect of Drug cluster around the peak (p \< 0.05 uncorrected) from the contrast maps across both groups. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks. |
| N-Back Task Activation in DLPFC in Patients With Schizophrenia | At end of treatment period (at 7th day for first intervention and at 21st day for second intervention) | Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p \< 0.05 uncorrected) from the contrast maps in patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks. |
| N-Back Task Activation in Healthy Volunteers | At end of treatment period (at 7th day for first intervention and at 21st day for second intervention) | Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p \< 0.05 uncorrected) from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks. |
| N-Back Task Activation Genotype Effect in Healthy Volunteers | At end of treatment period (at 7th day for first intervention and at 21st day for second intervention) | Activation beta values (N-Back vs. 0-Back) extracted within the Effect of Genotype cluster around the peak (p \< 0.05 uncorrected) in right and left DLPFC from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale | At end of treatment period (at 7th day for first intervention and at 21st day for second intervention) | Rating Scales PANSS. The Positive Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The Negative Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The General Scale ranges from 16 to 112, the higher score indicating greater severity of symptoms. |
Countries
United States
Participant flow
Recruitment details
Patients with schizophrenia were recruited through families, physicians and community organizations. Healthy volunteers were recruited through the NIH Normal Volunteers Office. Subjects first participated in Protocol # 95-M-0150 to obtain genotype data. If eligible after the study, they were invited to participate in the Tolcapone protocol.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers Tolcapone 200 mg 1 week:Wash Out 1 week:Placebo 1 week: (or vice versa) | 130 |
| Patients Tolcapone 200 mg 1 week:Wash Out 1 week:Placebo 1 week: (or vice versa) | 59 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (One Week)- HV's | Abnormal MRI | 0 | 1 |
| First Intervention (One Week)- HV's | Adverse Event | 1 | 0 |
| First Intervention (One Week)- HV's | Drank while on protocol | 0 | 1 |
| First Intervention (One Week)- HV's | Not follow directions | 2 | 2 |
| First Intervention (One Week)- HV's | Pregnancy | 1 | 0 |
| First Intervention (One Week)- HV's | Used illegal drugs | 1 | 0 |
| First Intervention (One Week)- HV's | Withdrawal by Subject | 5 | 3 |
| First Intervention (One Week) Patients | Not follow directions | 0 | 2 |
| First Intervention (One Week) Patients | Used illegal drug | 1 | 0 |
| Second Intervention (One Week) Patients | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Patients | Healthy Volunteers | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 130 Participants | 189 Participants |
| Age, Continuous | 26.9 years STANDARD_DEVIATION 6.8 | 34.5 years STANDARD_DEVIATION 9.1 | 32.1 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment United States | 59 participants | 130 participants | 189 participants |
| Sex: Female, Male Female | 18 Participants | 59 Participants | 77 Participants |
| Sex: Female, Male Male | 41 Participants | 71 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 0 / 131 | 0 / 59 | 0 / 60 |
| other Total, other adverse events | 25 / 131 | 29 / 131 | 17 / 59 | 22 / 60 |
| serious Total, serious adverse events | 0 / 131 | 0 / 131 | 0 / 59 | 0 / 60 |
Outcome results
Primary
N-Back Task Activation by Genotype in Patients With Schizophrenia
Activation beta values (N-Back vs. 0-Back) extracted from DLPFC from the contrast maps in Patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Population: 33 patients with schizophrenia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteer on Placebo | N-Back Task Activation by Genotype in Patients With Schizophrenia | left DLPFC | 0.28 beta value | Standard Error 0.04 |
| Healthy Volunteer on Placebo | N-Back Task Activation by Genotype in Patients With Schizophrenia | right DLPFC | 0.33 beta value | Standard Error 0.05 |
| Healthy Volunteer Tolcapone | N-Back Task Activation by Genotype in Patients With Schizophrenia | right DLPFC | 0.23 beta value | Standard Error 0.03 |
| Healthy Volunteer Tolcapone | N-Back Task Activation by Genotype in Patients With Schizophrenia | left DLPFC | 0.24 beta value | Standard Error 0.03 |
| Patient on Placebo | N-Back Task Activation by Genotype in Patients With Schizophrenia | right DLPFC | 0.24 beta value | Standard Error 0.04 |
| Patient on Placebo | N-Back Task Activation by Genotype in Patients With Schizophrenia | left DLPFC | 0.21 beta value | Standard Error 0.04 |
| Patients on Tolcapone | N-Back Task Activation by Genotype in Patients With Schizophrenia | right DLPFC | 0.25 beta value | Standard Error 0.05 |
| Patients on Tolcapone | N-Back Task Activation by Genotype in Patients With Schizophrenia | left DLPFC | 0.18 beta value | Standard Error 0.05 |
| Healthy Volunteer COMT Val/Met Genotype on Tolcapone | N-Back Task Activation by Genotype in Patients With Schizophrenia | right DLPFC | 0.20 beta value | Standard Error 0.03 |
| Healthy Volunteer COMT Val/Met Genotype on Tolcapone | N-Back Task Activation by Genotype in Patients With Schizophrenia | left DLPFC | 0.26 beta value | Standard Error 0.04 |
| Healthy Volunteer COMT Met/Met Genotype on Tolcapone | N-Back Task Activation by Genotype in Patients With Schizophrenia | right DLPFC | 0.22 beta value | Standard Error 0.03 |
| Healthy Volunteer COMT Met/Met Genotype on Tolcapone | N-Back Task Activation by Genotype in Patients With Schizophrenia | left DLPFC | 0.17 beta value | Standard Error 0.04 |
p-value: 0.189ANOVA
p-value: 0.041t-test, 1 sided
p-value: 0.718t-test, 1 sided
p-value: 0.469t-test, 1 sided
Primary
N-Back Task Activation Diagnosis Effect
Activation beta values (N-Back vs. 0-Back) were extracted within the Main Effect of Diagnosis cluster around the peak (p \< 0.05 uncorrected) from the contrast maps in the Placebo condition. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Population: 74 Healthy Volunteers and 33 Patients with Schizophrenia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteer on Placebo | N-Back Task Activation Diagnosis Effect | Right DLPFC | 0.15 beta value | Standard Error 0.02 |
| Healthy Volunteer on Placebo | N-Back Task Activation Diagnosis Effect | Left DLPFC | 0.18 beta value | Standard Error 0.02 |
| Healthy Volunteer Tolcapone | N-Back Task Activation Diagnosis Effect | Right DLPFC | 0.20 beta value | Standard Error 0.03 |
| Healthy Volunteer Tolcapone | N-Back Task Activation Diagnosis Effect | Left DLPFC | 0.23 beta value | Standard Error 0.03 |
p-value: <0.0001ANOVA
p-value: 0.014ANOVA
Primary
N-Back Task Activation Drug Effect
Activation beta values (N-Back vs. 0-Back) extracted within the Main Effect of Drug cluster around the peak (p \< 0.05 uncorrected) from the contrast maps across both groups. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Population: 74 Healthy Volunteers and 33 Patients with Schizophrenia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteer on Placebo | N-Back Task Activation Drug Effect | Right DLPFC | 0.09 beta value | Standard Error 0.03 |
| Healthy Volunteer on Placebo | N-Back Task Activation Drug Effect | Left DLPFC | 0.27 beta value | Standard Error 0.04 |
| Healthy Volunteer Tolcapone | N-Back Task Activation Drug Effect | Left DLPFC | 0.25 beta value | Standard Error 0.04 |
| Healthy Volunteer Tolcapone | N-Back Task Activation Drug Effect | Right DLPFC | 0.11 beta value | Standard Error 0.02 |
| Patient on Placebo | N-Back Task Activation Drug Effect | Right DLPFC | 0.12 beta value | Standard Error 0.04 |
| Patient on Placebo | N-Back Task Activation Drug Effect | Left DLPFC | 0.23 beta value | Standard Error 0.05 |
| Patients on Tolcapone | N-Back Task Activation Drug Effect | Right DLPFC | 0.07 beta value | Standard Error 0.03 |
| Patients on Tolcapone | N-Back Task Activation Drug Effect | Left DLPFC | 0.09 beta value | Standard Error 0.06 |
p-value: 0.05ANOVA
p-value: 0.32ANOVA
Primary
N-Back Task Activation Genotype Effect in Healthy Volunteers
Activation beta values (N-Back vs. 0-Back) extracted within the Effect of Genotype cluster around the peak (p \< 0.05 uncorrected) in right and left DLPFC from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteer on Placebo | N-Back Task Activation Genotype Effect in Healthy Volunteers | Right DLPFC | 0.22 beta value | Standard Error 0.03 |
| Healthy Volunteer on Placebo | N-Back Task Activation Genotype Effect in Healthy Volunteers | Left DLPFC | 0.14 beta value | Standard Error 0.03 |
| Healthy Volunteer Tolcapone | N-Back Task Activation Genotype Effect in Healthy Volunteers | Right DLPFC | 0.23 beta value | Standard Error 0.03 |
| Healthy Volunteer Tolcapone | N-Back Task Activation Genotype Effect in Healthy Volunteers | Left DLPFC | 0.19 beta value | Standard Error 0.03 |
| Patient on Placebo | N-Back Task Activation Genotype Effect in Healthy Volunteers | Right DLPFC | 0.14 beta value | Standard Error 0.04 |
| Patient on Placebo | N-Back Task Activation Genotype Effect in Healthy Volunteers | Left DLPFC | 0.10 beta value | Standard Error 0.03 |
| Patients on Tolcapone | N-Back Task Activation Genotype Effect in Healthy Volunteers | Right DLPFC | 0.22 beta value | Standard Error 0.03 |
| Patients on Tolcapone | N-Back Task Activation Genotype Effect in Healthy Volunteers | Left DLPFC | 0.14 beta value | Standard Error 0.03 |
| Healthy Volunteer COMT Val/Met Genotype on Tolcapone | N-Back Task Activation Genotype Effect in Healthy Volunteers | Right DLPFC | 0.25 beta value | Standard Error 0.03 |
| Healthy Volunteer COMT Val/Met Genotype on Tolcapone | N-Back Task Activation Genotype Effect in Healthy Volunteers | Left DLPFC | 0.18 beta value | Standard Error 0.03 |
| Healthy Volunteer COMT Met/Met Genotype on Tolcapone | N-Back Task Activation Genotype Effect in Healthy Volunteers | Right DLPFC | 0.15 beta value | Standard Error 0.04 |
| Healthy Volunteer COMT Met/Met Genotype on Tolcapone | N-Back Task Activation Genotype Effect in Healthy Volunteers | Left DLPFC | 0.09 beta value | Standard Error 0.04 |
p-value: <0.0001ANOVA
p-value: 0.167ANOVA
Primary
N-Back Task Activation in DLPFC in Patients With Schizophrenia
Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p \< 0.05 uncorrected) from the contrast maps in patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Population: 33 Patients with Schizophrenia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteer on Placebo | N-Back Task Activation in DLPFC in Patients With Schizophrenia | Right DLPFC | 0.26 beta value | Standard Error 0.02 |
| Healthy Volunteer on Placebo | N-Back Task Activation in DLPFC in Patients With Schizophrenia | Left DLPFC | 0.25 beta value | Standard Error 0.02 |
| Healthy Volunteer Tolcapone | N-Back Task Activation in DLPFC in Patients With Schizophrenia | Right DLPFC | 0.24 beta value | Standard Error 0.018 |
| Healthy Volunteer Tolcapone | N-Back Task Activation in DLPFC in Patients With Schizophrenia | Left DLPFC | 0.23 beta value | Standard Error 0.02 |
p-value: 0.05t-test, 1 sided
p-value: 0.078t-test, 1 sided
Primary
N-Back Task Activation in Healthy Volunteers
Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p \< 0.05 uncorrected) from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Population: 74 Healthy Volunteers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteer on Placebo | N-Back Task Activation in Healthy Volunteers | Right DLPFC | 0.09 beta value | Standard Error 0.03 |
| Healthy Volunteer on Placebo | N-Back Task Activation in Healthy Volunteers | Left DLPFC | 0.38 beta value | Standard Error 0.03 |
| Healthy Volunteer Tolcapone | N-Back Task Activation in Healthy Volunteers | Right DLPFC | 0.11 beta value | Standard Error 0.02 |
| Healthy Volunteer Tolcapone | N-Back Task Activation in Healthy Volunteers | Left DLPFC | 0.36 beta value | Standard Error 0.03 |
p-value: 0.05t-test, 1 sided
p-value: 0.73t-test, 1 sided
Primary
N-Back Task Performance
Working Memory was measured in HVs and patients with schizophrenia after a 7-day treatment with Tolcapone or placebo in a double-blind, cross-over fashion. The working memory was quantified by taking the number of trials entered correctly divided by the total number of trials multiplied by 100. Values range from 0 to 100. Zero indicates the poorest performance while 100 indicates perfect performance.
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Population: 147 HV's recruited, 8 left after signing consents, 8 excluded for other reasons, 57 excluded for excessive motion, inferior quality or not completion. 63 patients recruited, 4 removed for different reasons, 26 excluded from image analyses for not completing the second phase of the study, excessive motion or bad image quality.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Volunteer on Placebo | N-Back Task Performance | 86.10 % of Correct Trials | Standard Error 1.13 |
| Healthy Volunteer Tolcapone | N-Back Task Performance | 85.50 % of Correct Trials | Standard Error 1.1 |
| Patient on Placebo | N-Back Task Performance | 76.21 % of Correct Trials | Standard Error 2.31 |
| Patients on Tolcapone | N-Back Task Performance | 80.94 % of Correct Trials | Standard Error 1.9 |
p-value: <0.0001ANOVA
p-value: 0.0034ANOVA
Secondary
Positive and Negative Syndrome Scale
Rating Scales PANSS. The Positive Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The Negative Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The General Scale ranges from 16 to 112, the higher score indicating greater severity of symptoms.
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Population: There were 74 Healthy Volunteers and 33 Patients with Schizophrenia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteer on Placebo | Positive and Negative Syndrome Scale | Positive Subscale | 7.01 units on a scale | Standard Deviation 0.01 |
| Healthy Volunteer on Placebo | Positive and Negative Syndrome Scale | General Psychopathology | 16.36 units on a scale | Standard Deviation 0.1 |
| Healthy Volunteer on Placebo | Positive and Negative Syndrome Scale | Negative Subscale | 7.36 units on a scale | Standard Deviation 0.14 |
| Healthy Volunteer Tolcapone | Positive and Negative Syndrome Scale | Positive Subscale | 7.02 units on a scale | Standard Deviation 0.03 |
| Healthy Volunteer Tolcapone | Positive and Negative Syndrome Scale | General Psychopathology | 16.33 units on a scale | Standard Deviation 0.09 |
| Healthy Volunteer Tolcapone | Positive and Negative Syndrome Scale | Negative Subscale | 7.27 units on a scale | Standard Deviation 0.13 |
| Patient on Placebo | Positive and Negative Syndrome Scale | Negative Subscale | 16.51 units on a scale | Standard Deviation 1 |
| Patient on Placebo | Positive and Negative Syndrome Scale | Positive Subscale | 12.15 units on a scale | Standard Deviation 0.51 |
| Patient on Placebo | Positive and Negative Syndrome Scale | General Psychopathology | 27.12 units on a scale | Standard Deviation 0.78 |
| Patients on Tolcapone | Positive and Negative Syndrome Scale | Positive Subscale | 12 units on a scale | Standard Deviation 0.54 |
| Patients on Tolcapone | Positive and Negative Syndrome Scale | General Psychopathology | 26.24 units on a scale | Standard Deviation 0.84 |
| Patients on Tolcapone | Positive and Negative Syndrome Scale | Negative Subscale | 15.88 units on a scale | Standard Deviation 1.02 |
p-value: 0.7t-test, 1 sided
p-value: 0.4t-test, 1 sided
p-value: 0.12t-test, 1 sided